Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)

Exclusion Criteria

• •1. Any active pathological heart, muscular, neurological, orthopedic, cognitive or pulmonary disease which might interfere with patient compliance or ability to walk on a treadmill in the opinion of the investigator.
• •2. Non compressible arteries as defined by ABI\>1.1
• •3. Clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave Doppler in the affected extremity.
• •4. Deep venous insufficiency on clinical grounds or by lab measurements.
• •5. Prior below-knee surgical revascularization procedure within the last 6 months.
• •6. Significant likelihood of lower extremity arterial revascularization procedure within the next 6 months.
• •7. Ulcer, cellulitis, skin conditions, or superficial thrombophlebitis in regions covered by the compression device preventing use of the device.
• •8. Acute pulmonary embolism.
• •9. Osteomyelitis of the lower extremity.
• •10. Gangrene of the lower extremity.
• •11. Acute limb ischemia.
• •12. Clinical scenarios in which increased venous or lymphatic return is undesirable.
• •13. Painful calf conditions which would exclude use of the pump.
• •14. Peripheral neuropathy that, in the opinion of the investigator, would prevent patient from accurately assessing claudication symptoms or identifying Cutaneous comfort of the device Vein ligation.
• •15. Pulmonary edema.
• •16. Significant aorto-iliac disease as demonstrated by physical examination or objective testing. Absence of aorto-iliac disease must be documented by segmental testing performed within 90 days of study enrollment.
• •17. Critical leg ischemia with evidence of rest pain, ischemic ulceration, gangrene.
• •18. Participation in any clinical trial within the past 30 days.
• •19. Morbid obesity, defined by BMI\>40, weight greater than 300 lbs or leg circumference greater than 19.7 inches.
• •20. Pregnancy.